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417 device results listed.

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FT4 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208081
Basic UDI-DI: B-06933260208081
Reference: BT2215
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

FT3 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208074
Basic UDI-DI: B-06933260208074
Reference: BT2214
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

hscTnI Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208067
Basic UDI-DI: B-06933260208067
Reference: BT0201201
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

CCP Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208050
Basic UDI-DI: B-06933260208050
Reference: BT0201101
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

RF Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208043
Basic UDI-DI: B-06933260208043
Reference: BT0201001
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

ASO Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208036
Basic UDI-DI: B-06933260208036
Reference: BT0200901
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/D-Dimer/BNP Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208029
Basic UDI-DI: B-06933260208029
Reference: BT0200801
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

TRF Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208012
Basic UDI-DI: B-06933260208012
Reference: BT2222
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Lp-PLA2 Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208005
Basic UDI-DI: B-06933260208005
Reference: BT2223
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema pallidum Antibody Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207992
Basic UDI-DI: B-06933260207992
Reference: BT0102701
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Antigen Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207985
Basic UDI-DI: B-06933260207985
Reference: BT0102601
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasmal Pneumonia IgM Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207978
Basic UDI-DI: B-06933260207978
Reference: BT0102501
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207961
Basic UDI-DI: B-06933260207961
Reference: BT0200701
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

25(OH)-D Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207954
Basic UDI-DI: B-06933260207954
Reference: BT2801
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

PG I/PGII/G17 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207947
Basic UDI-DI: B-06933260207947
Reference: BT0200601
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

s100-β Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207930
Basic UDI-DI: B-06933260207930
Reference: BT0200501
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

NSE Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207923
Basic UDI-DI: B-06933260207923
Reference: BT0200401
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

BIOTIME

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207824
Basic UDI-DI: B-06933260207824
Reference: BT0507201
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207619
Basic UDI-DI: B-06933260207619
Reference: BT0506305
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207602
Basic UDI-DI: B-06933260207602
Reference: BT0506304
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details